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ProgramAntibody biosimilars: fears or opportunities?May 28th 2013, Vinci International Congress Centre, Tours8h30-9h: Welcome9h-9h30: Introduction9h30-11h: 1st session - Market and regulatory issues
Brief overview of the IP landscape in the medical field. When do (Biotech) patents actually expire? Of SPCs, PEs and PTEs André Bourgouin, Partner, Grosset-Fournier & Demachy, Paris, France Regulatory perspective on biosimilar in the EU Kowid Ho, ANSM, Department for evaluation of biological products, France Challenges to Develop and Implement a Manufacturing Process for Biosimilars Steve Flatman, Head of Biosimilars R&D at Lonza, UK 11h-11h30: Coffee break11h30-13h: 2nd Session - Quality control attributes, bioequivalence and formulation
Acceptable changes in quality attributes of antibodies and assimilated biopharmaceuticals Hansjörg Toll, Analytical Characterization group, Sandoz Biopharmaceuticals, Kundl, Austria Myths and Facts around Consistent Quality of Biotech Products John Stults, Director of the Protein Analytical Chemistry Department, Genentech, USA Functional in vitro assays for evaluating the Fc function of therapeutic monoclonal antibodies: issues and proposed strategies Chritian Behrens, LFB Biotechnologies, Les Ulis, France 13h-14h30: Lunch14h30-16h: 3rd session - Development of biosimilars
EU clinical requirements Marie-Christine Bielsky, Medicines and Healthcare products Regulatory Agency, London, UK Clinical evaluation of Remsima®, an infliximab biosimilar Dae Hyun Yoo, Department of Internal Medicine, Hospital for rheumatic Diseases, Hanyang University, South Korea Indication extrapolation for biosimilar monoclonal antibodies Valentine Sallerin, Global Medical Affairs, AbbVie Pharmaceuticals, France 16h-16h30: Coffee break16h30-17h30: 4th session - Societal issues
Pressure on the Health Economy - why we need Biosimilars Paul Greenland, Vice President Biologics, Hospira UK Ethical issues about clinical evaluation of biosimilars Emmanuel Gyan, CHRU and Université François-Rabelais de Tours, France |
